Top 13 Quality engineer Jobs in Saco, Me

Quality Engineer II (Medical Devices / Risk Management)
Intellectt Inc —Scarborough, ME
- $40 - $44 an hour
- Contract
- Engineering
- Mid-level
- 3 years
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14h
Quality Engineer
Fiber Materials —Biddeford, ME
- 5 years
- Mid-level
- Windows
- Paid holidays
- Health insurance
Supplier Quality Engineer
Abbott Laboratories —Scarborough, ME
- $61,300 - $122,700 a year
- Full-time
- Engineering
- Senior level
- Leadership
- Health insurance
- Tuition reimbursement
7d
Quality Engineer II
Nova Biomedical —Westbrook, ME
- $85,000 - $95,000 a year
- Full-time
- Bachelor of Science
- Engineering
- Mid-level
- Paid holidays
- Health insurance
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Inspection Tester #1
General Dynamics Ordnance & Tactical Systems —Saco, ME
- $35.41 an hour
- Full-time
- Computer literacy
- Mid-level
- High school diploma or GED
Prin Supplier QA Engineer (Remote/Southern California)
General Dynamics Ordnance & Tactical Systems —Saco, ME
- $125,000 - $162,500 a year
- Full-time
- Microsoft Excel
- Up to 50% travel
- 8 years
- Commuter assistance
- Paid holidays
Testing Manager
Harvey Performance Operating —Gorham, ME
- No experience needed
- Mentoring
- Manufacturing
- Profit sharing
- Paid holidays
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Quality and Supply Chain Manager
Yokogawa Fluid Imaging Technologies, Inc. —Scarborough, ME
Establish and monitor key quality metrics (e.g., yield, defects, field performance, customer complaints) and lead corrective and preventive actions (CAPA).
From $100,000 a year
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Quality Control Inspector – Closer
Extrusion Alternatives, Inc —Portsmouth, NH
Experience with measuring devices such as micrometers, vision scope, computers, rulers, measuring tape, calipers, and other measuring instruments.
$20 - $21 an hour
Quick Apply

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quality engineer jobs near saco, me

Quality Engineer II (Medical Devices / Risk Management)

Intellectt Inc
Scarborough, ME

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Job Details

Contract
$40 - $44 an hour
14 hours ago

Qualifications

Customer communication
Health & safety investigations
Conducting hazard assessments
Technical documentation
ISO standards
Safety regulations
GMP
Quality risk management
Continuous improvement
Quality improvement
Technical writing
Regulatory/legal compliance standards in production
Biomedical regulatory compliance
Quality audits
Occupational safety risk assessments
Hazard mitigation
Cross-functional communication
FDA regulations
Customer complaint resolution

Full Job Description

Job Summary:
The Quality Engineer II is responsible for supporting product risk management activities throughout the product lifecycle, ensuring compliance with FDA regulations, ISO standards, and company quality requirements. This role works closely with Engineering, Manufacturing, Regulatory Affairs, Quality Assurance, and Product Development teams to perform risk assessments, investigate product complaints and non-conformances, and maintain accurate, audit-ready risk management documentation. The position also focuses on driving continuous improvement of risk management processes while ensuring product safety, quality, and regulatory compliance.

Key Responsibilities:

Perform product risk evaluations related to customer complaints, manufacturing non-conformances, and new product development activities.
Conduct hazard analyses, risk assessments, and risk mitigation activities in accordance with ISO 14971.
Develop, review, and maintain product risk management documentation throughout the product lifecycle.
Collaborate with Engineering, Manufacturing, Regulatory Affairs, Quality Assurance, Marketing, and Design Assurance teams to establish and maintain compliant risk documentation.
Support complaint investigations and Health Hazard Assessments (HHA) for marketed products.
Identify opportunities for continuous improvement within risk management and quality processes.
Ensure compliance with FDA regulations, GMP requirements, ISO standards, and internal Quality Management System (QMS) procedures.
Participate in quality investigations, root cause analysis, and resolution of product quality issues.
Support internal and external quality audits and ensure documentation is complete and audit-ready.
Communicate effectively with internal teams, contractors, vendors, and customers to resolve quality-related issues.

Required Qualifications:

Bachelor's degree in Engineering or a related technical discipline.
Minimum 3 years of Quality Engineering experience in a regulated industry such as medical devices, pharmaceuticals, or biotechnology.
Hands-on experience with product risk management, hazard analysis, and risk assessment using ISO 14971.
Experience supporting complaint investigations, non-conformance evaluations, or Health Hazard Assessments.
Working knowledge of FDA regulations, GMP, ISO standards, and Quality Management Systems.
Strong analytical, problem-solving, documentation, and technical communication skills.
Demonstrated ability to collaborate effectively with cross-functional teams.

Preferred:

Certified Quality Engineer (CQE) or equivalent
Experience with GMP environments and quality system audits
Exposure to new product development and design assurance activities

Pay: $40.00 - $44.00 per hour

Work Location: In person

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quality engineer jobs in saco, me

Quality Engineer II (Medical Devices / Risk Management)

Quality Engineer

Supplier Quality Engineer

Quality Engineer II

Inspection Tester #1

Prin Supplier QA Engineer (Remote/Southern California)

Testing Manager

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